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Senior Scientific/Regulatory Writer

2+ years
Not Disclosed
10 Sept. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary

The role involves writing, reviewing, and managing the production of high-quality clinical and safety documentation for regulatory submissions, supporting marketing applications. It also provides consultancy on documentation to other functions.

About the Role

Position: Medical Writer
Location: Dublin, Ireland (with remote options available in the UK or Hyderabad, India)

Major Accountabilities:

  • Serve as a core member of the Clinical Trial Team (CTT) and participate in Safety Management Teams (SMT).
  • Actively contribute to the planning of data analyses and presentations used in Clinical Study Reports (CSRs).
  • Function as a documentation consultant within CTTs and SMTs, ensuring compliance with internal standards and external regulatory guidelines.
  • May act as a Program Writer, ensuring adequate medical writing resources are available and maintaining consistency across documents.
  • Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.
  • Oversee the distribution of marketing samples, where applicable.

Key Performance Indicators:

  • Timely delivery of high-quality clinical and safety documents in compliance with internal and external standards.
  • Positive feedback and satisfaction from customers, partners, and projects.
  • Adherence to Novartis policies and guidelines.

Minimum Requirements:

Work Experience:

  • Functional breadth across various domains.
  • Cross-cultural experience and collaboration across boundaries.
  • Operations management and execution expertise.

Skills:

  • Strong background in clinical research and clinical trials.
  • Detail-oriented with excellent medical writing capabilities.
  • Knowledge of regulatory compliance and safety protocols.

Languages:

  • Proficiency in English.

Why Novartis?

At Novartis, we are committed to improving the lives of patients and their families. It takes a community of passionate individuals to drive innovative science. Join us in collaborating and inspiring each other to achieve breakthroughs that change lives. Learn more about our mission here.

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Benefits and Rewards

Discover all the ways we support your personal and professional growth in the Novartis Life Handbook here.


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